A Warning From California

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FDA and FTC Issue Warning Letters to Seven Companies Selling Fraudulent  COVID-19 'Treatments' | BioSpace

Over the last year, COVID-19 has taught us painful lessons about the pitfalls of wishful thinking. Early in the pandemic, some people speculated that the virus would slow down over as the weather got warmer over the summer months; instead, the U.S. experienced a deadly wave of new cases. A few months ago, I hoped that here in Southern California, it would be easier for people to avoid spreading the virus than in colder parts of the country, because people can socially distance outdoors more easily year-round. Instead, our outbreak is now among the world’s deadliest—on Monday, California became the first state to report more than 3 million cases of the virus. Here in Los Angeles County, so many people are dying that officials temporarily lifted air quality regulations to permit more cremations, the Los Angeles Times reports.

California’s struggles to contain COVID-19 can at least partly be attributed to pandemic fatigue—after nearly a year of wearing masks and avoiding contact with others, people’s resolve is simply wearing thin. However, while we may feel done with the virus, it isn’t done with us—between 70 and nearly 120 people per 100,000 have died of COVID-19 in California every day in the last week, while more than 3,200 have died each day nationwide; the U.S. just today passed the grim milestone of 400,000 COVID-19 deaths.

If California can’t get its outbreak under control, more pain could lie ahead. Officials have discovered that new variants of the virus are spreading in the Golden State, including a more transmissible strain first identified in the U.K., where caseloads are skyrocketing and hospitals are overwhelmed. What’s happening here in California could be a bellwether for the rest of the country, as the virus continues its spread mostly unchecked across the country and world.

Regardless of which variant is spreading, experts say the defensive measures remain the same: we need to keep wearing our masks (new research shows just how effective they are), maintaining physical distance from others, and spend as much time as possible at home. It’s natural to want to give up—or even bend just a little—and spend time with friends and family we haven’t seen in ages, or do other risky things. That temptation is all the more real now that multiple highly effective vaccines are here, and the end of the pandemic seems within sight. But the vaccination process has gone frustratingly slowly so far, and not enough of us have the necessary protection to let our collective guard down, especially given the presence of at least one highly transmissible mutation.

With those alarming new variants spreading across the globe, it’s probably time to recalibrate our behavior in favor of safety—until more people are inoculated, it’s vital for us to reduce spread through other proven means. In the coming weeks, Californians and Americans elsewhere must buckle down, with their eyes on the final mission: ensuring that as many people as possible survive to see the end of the pandemic.

VACCINE TRACKER

While 28.4 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this morning, only about 10.6 million doses have been administered thus far, according to TIME’s vaccine trackerrepresenting 3.2% of the overall U.S. population.

India launched its nationwide coronavirus vaccine rollout on Saturday, starting with healthcare workers, according to the New York Times. Prime Minister Narendra Modi has said that the 1.3 billion-person country aims to vaccinate 300 million healthcare and other front line workers by July. More than 10.5 million people have been infected in India, and more than 152,500 people have died.

Yesterday, New York Governor Andrew Cuomo asked Pfizer whether his state could purchase vaccines directly from the pharmaceutical company, thus bypassing the federal government. But Dr. Celine Gounder, who’s advising President-elect Joe Biden on the pandemic, said that such a strategy could create problems. “I think we’ve already had too much of a patchwork response across the states,” Grounder said in an interview with CNBC today; she also argued that Cuomo’s idea could create a bidding war among states for vaccines.

TODAY’S CORONAVIRUS OUTLOOK

The Global Situation

More than 95.5 million people around the world had been diagnosed with COVID-19 as of 3 p.m. E.T. today, and more than 2 million people have died. On Jan. 18, there were 514,013 new cases and 9,276 new deaths confirmed globally.

Here’s how the world as a whole is currently trending:

Here’s where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:

And here is every country with over 1.5 million confirmed cases:

Hua Chunying, a spokeswoman for China’s foreign ministry, is pushing back on findings from an independent World Health Organization report that was critical of Beijing’s early response to the COVID-19 outbreak. China’s early lockdowns, Chunying said, helped reduce deaths and infections, Al Jazeera reports. Still, China has been criticized for failing to adequately disclose the scope and nature of the outbreak when it first began.

German leaders have agreed to extend a lockdown for businesses and schools until Feb. 14 and to require medical masks on public transportation, Reuters reports. While Germany is now reporting fewer than half as many new cases as it was a month ago, experts have raised concerns about new coronavirus variants that are thought to be more contagious, some of which have been detected in the country.

The Situation in the U.S.

The U.S. had recorded more than 24 million coronavirus cases as of 3 p.m. E.T. today. More than 400,000 people have died. On Jan. 18, there were 141,999 new cases and 2,422 new deaths confirmed in the U.S.

Here’s how the country as a whole is currently trending:

And here’s where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents.

President-elect Joe Biden plans to continue a travel ban on non-U.S. citizens from European countries and Brazil, reversing outgoing President Donald Trump’s order to end the ban on Jan. 26, six days into Biden’s presidency. Jennifer Psaki, Biden’s incoming press secretary, tweeted that the Biden administration plans “to strengthen public health measures around international travel.” A week ago, the U.S. Centers for Disease Control and Prevention ordered that almost all airline passengers must have a negative coronavirus test or proof of recovery before entering the U.S.

US passes 400,000 coronavirus deaths

https://thehill.com/policy/healthcare/534765-us-passes-400000-coronavirus-deaths?rnd=1611069180

COVID update: US passes 400,000 deaths; Rebekah Jones arrested

The United States on Tuesday passed 400,000 deaths from COVID-19, a stunning total that is only climbing as the crisis deepens. 

The country is now averaging more than 3,000 coronavirus deaths every day, according to Johns Hopkins University data, more than the number of people killed in the Sept. 11, 2001, terror attacks, and the daily death toll has been rising. The effects of a surge in gatherings and travel over the holidays are now coming into focus. 

The grim milestone of 400,000 deaths came on the last full day in office for President Trump, who has long rejected criticism of his handling of the pandemic.

The situation threatens to get even worse as a new, more contagious variant of the virus becomes more prevalent. The Centers for Disease Control and Prevention (CDC) warned last week that one of the new variants, first discovered in the United Kingdom, could be the predominant strain in the U.S. by March. 

Vaccines offer hope, but it is crucial for the inoculation campaign to progress as quickly as possible to get as many people protected before the new variant takes greater hold. 

The U.S. vaccination campaign has started slowly, though there are signs it is beginning to pick up some speed. President-elect Joe Biden has pledged a more aggressive federal role in the vaccination effort, including using the National Guard and the Federal Emergency Management Agency to set up more vaccination sites.

In the short term, however, the country is in for a bleak period. 

Biden’s incoming CDC director, Rochelle Walensky, said Sunday on CBS’s “Face the Nation” that she expects 500,000 COVID-19 deaths by the middle of February. 

“I think we still have some dark weeks ahead,” she said. 

The country passed 300,000 deaths in mid-December.

At the end of March, as the crisis was beginning, Trump said that if deaths are limited to between 100,000 and 200,000 “we all, together, have done a very good job.” The country has long ago exceeded those numbers. 

The U.S. has by far the most COVID-19 deaths of any country in the world. Brazil follows with around 210,000, and India and Mexico are around 150,000, according to Johns Hopkins University. 

More than 124,000 people are in the hospital with coronavirus in the U.S., according to the COVID Tracking Project, though the number is starting to decline somewhat from a peak of over 130,000 about a week ago. 

The spread of the more contagious variant, however, threatens to send that number spiking again.

Whatever Affects One Directly, Affects All Indirectly

Apple once more dedicates homepage to celebrating Martin Luther King Jr Day  - 9to5Mac

Another coronavirus variant linked to growing share of cases, several large outbreaks, in California

Coroner Elizabeth Napoles, right, of the Los Angeles County Department of Medical Examiner, works with National Guardsmen, helping to store the bodies of covid-19 victims last week. 

Health officials stress they haven’t determined whether the variant might be more contagious or resistant to vaccines.

coronavirus variant first identified in Denmark has ripped through Northern California — including outbreaks at nursing homes, jails and a hospital in the San Jose area — prompting state and local officials to investigate whether it may be more transmissible.

California officials disclosed the rise of the variant Sunday night after genetic monitoring linked it to a fast-growing share of new cases, as well as to the outbreaks in Santa Clara county, which includes San Jose.

This rising variant is distinct from the highly contagious mutation discovered by Britain, which has also been found in California, and which federal health officials project could become the dominant strain in the United States by March based on its proven higher transmissibility.

Experts stress that they need to look more closely at the circumstances of the Northern California outbreaks, as well as at the latest variant — this one, known as L452R — before declaring it more contagious or more dangerous than the virus already broadly circulating.

The L452R variant was first detected in northern Europe in March and has since been confirmed in more than a dozen states, including California in May. The discovery did not garner much attention at the time because all viruses change constantly as they replicate. But public health authorities deem some variants to be “of concern” if evidence suggests they might be more contagious, potentially deadlier or resistant to vaccines.

California publicized the latest variant at a late Sunday news conference after researchers identified it in about 25 percent of samples collected between Dec. 14 and Jan. 3, a surge from 3.8 percent of samples collected in the preceding three-week period.

“That is suggestive, and it’s a little worrisome,” Charles Chiu, a virologist at the University of California at San Francisco said at the briefing. But Chiu stressed it was too early to conclude the variant is more infectious because scientists do not know whether their sampling was representative or whether the variant’s increase might be due to random chance, or even a series of superspreader events.

Officials urged people to follow public health guidelines to minimize the risk of contracting the variant as new daily cases in the hard-hit state plateau at more than 38,000, while deaths average more than 515 daily.

“It’s too soon to know if this variant will spread more rapidly than others,” said Erica Pan, California’s state epidemiologist, “but it certainly reinforces the need for all Californians to wear masks and reduce mixing with people outside their immediate households to help slow the spread of the virus.”

Genetic sequencing of viruses is still limited in the United States, preventing health officials from having a real-time picture of all the strains of coronavirus spreading across the country and their prevalence.

California’s preliminary data is based on fewer than 400 samples that overwhelmingly came from the state’s north. Southern California is the heaviest hit part of the state, with deaths in Los Angeles County reaching one every seven minutes and ICU beds and oxygen running out, although hospitalizations have begun to plateau. Environmental regulators on Sunday temporarily lifted limits on cremations because of a backlog in Los Angeles County.

The L452R strain in California raised alarms because it is associated with several large outbreaks in Santa Clara County, including one at a hospital that infected at least 90 people and killed one staff member. Officials at Kaiser Permanente San Jose Medical Center said a staff member wearing an inflatable Christmas tree costume to spread holiday cheer likely spread coronavirus-laden droplets instead.

A Kaiser Permanente employee died and dozens of others contracted the coronavirus after a staffer appeared at the San Jose medical center wearing an inflatable, air-powered holiday costume on Christmas Day.

Sara Cody, Santa Clara’s top public health official, described that episode as a “very unusual outbreak with a lot of illnesses, and it seemed to spread quite fast.” The county is working with state health officials and the CDC to investigate what happened, she said.

Cody cautioned that the outbreak could have been driven by factors unrelated to the variant, such as changes in ventilation or personal protective equipment practices at the hospital.

“The takeaway is not that we need to start worrying about this,” Cody said Sunday. “The takeaway is, this is a variant that’s becoming more prevalent, and we need to lean in and understand more about it.”

County officials on Monday disclosed other places where the variant had been found as a result of aggressive genetic sequencing, “including cases associated with the Kaiser outbreak, skilled nursing facility outbreaks, cases in jails and shelters, and specimens from testing sites in the community,” according to a statement. “This suggests that the variant is now relatively common in our community.”

Chiu, the virologist who conducted the genetic sequencing, said a deeper investigation must be done to determine if the strain is more transmissible like the one found in the United Kingdom.

He also raised concerns that a mutation associated with the variant might make it more resistant to vaccines because it occurs in a critical part of the spike protein that is targeted by the vaccines,but he added that the virus must be grown in a lab and tested more fully before any conclusions can be drawn.

“Mutations happen all the time,” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health. “Some of them take off and the great majority of them don’t. The main reason why we are paying attention to this is because this mutation has previously been noted as being of particular concern in terms of diminishing the efficacy of the immune response.”

Carlos del Rio, a professor of medicine and global health at Emory University, said the rising prevalence of the variant shows the urgent need for more genetic sequencing in the United States and for greater compliance with public health measures such as wearing masks and avoiding crowds.

“We really need to hunker down because if you are really concerned about mutations, stop transmission,” del Rio said. “The more mutations you see, the more uncontrolled transmission you will see.”

After starting the new year with record-high cases, deaths and hospitalizations, the United States is starting to see signs of slowing spread despite fears of a post-holiday surge that would continue through January. The seven-day average of new infections has slowed since last Tuesday, and hospitalizations have started to plateau, according to Washington Post tracking.

Still, Scott Gottlieb, a former Food and Drug Administration commissioner, warned that the advent of more transmissible variants could reverse that progress.

“As current epidemic surge peaks, we may see 3-4 weeks of declines in new cases but then new variant will take over,” Gottlieb tweeted Sunday, referring to the British variant. “It’ll double in prevalence about every week. It’ll change the game and could mean we have persistent high infection through spring until we vaccinate enough people.”

Trump moves to lift coronavirus travel restrictions on Europe, Brazil

https://thehill.com/homenews/administration/534718-trump-moves-to-lift-travel-restrictions-on-europe-brazil?rnd=1611014258

Trump moves to lift coronavirus travel restrictions on Europe, Brazil |  TheHill


President Trump on Monday moved to lift restrictions imposed on travelers to the U.S. from much of Europe and Brazil that were implemented last year to slow the spread of the novel coronavirus, though the action is expected to be stopped by the incoming Biden administration.

Trump issued an executive order terminating the travel restrictions on the United Kingdom, Ireland, Brazil and the countries in Europe that compose the Schengen Area effective Jan. 26. The order came two days before Trump leaves office. President-elect Joe Biden’s team immediately signaled they would move to reverse the order.

“With the pandemic worsening, and more contagious variants emerging around the world, this is not the time to be lifting restrictions on international travel,” tweeted incoming White House press secretary Jen Psaki.

“On the advice of our medical team, the Administration does not intend to lift these restrictions on 1/26. In fact, we plan to strengthen public health measures around international travel in order to further mitigate the spread of COVID-19,” Psaki continued.

The order states that Trump’s action came at the recommendation of outgoing Health and Human Services Secretary Alex Azar. The memo cites the new order from the Centers for Disease Control and Prevention (CDC) that requires passengers traveling by air to the U.S. to receive a negative COVID-19 test within three days before their flight departs, saying it will help prevent travelers from spreading the virus.

The Trump administration’s travel restrictions on China and Iran will remain in place, however, because, the order states, the countries “repeatedly have failed to cooperate with the United States public health authorities and to share timely, accurate information about the spread of the virus” and therefore cannot be trusted to implement the CDC’s order.

“Accordingly, the Secretary has advised me to remove the restrictions applicable to the Schengen Area, the United Kingdom, the Republic of Ireland, and the Federative Republic of Brazil, while leaving in place the restrictions applicable to the People’s Republic of China and the Islamic Republic of Iran,” Trump’s order states. “I agree with the Secretary that this action is the best way to continue protecting Americans from COVID-19 while enabling travel to resume safely.”

Though Trump signed the order on Monday, the action does not take effect until six days after he leaves office and Biden is inaugurated. 

The order comes as coronavirus cases and deaths continue to hit worrisome, record-high levels on a daily basis. Nearly 400,000 people in the U.S. and more than 2 million people globally have died from COVID-19. While two vaccines have been approved for emergency use in the U.S., the Trump administration has fallen far short of early targets in distributing and administering the vaccine.

The order will be one of the final actions that Trump takes with respect to the pandemic, after being widely criticized for regularly minimizing the threat posed by the virus.

Trump announced in mid-March of last year that he would impose travel restrictions on individuals entering the United States from the 26 countries that compose the Schengen Area, weeks after the first case was reported in the U.S. The move initially attracted scrutiny because it did not include the U.K. or Ireland, and the Trump administration later moved to restrict travel from those countries as well.

Trump later placed travel restrictions on Brazil at the end of May.

The executive order lifting the travel restrictions was one of several released by the White House on Monday as the final hours of Trump’s presidency wind down. Trump is also expected to grant a final slew of pardons before he leaves office on Wednesday. 

The United States could hit half a million covid-19 deaths by mid-February

“It took 12 weeks for the death toll to rise from 200,000 to 300,000. The death toll has leaped from 300,000 to almost 400,000 in less than five weeks,” The Post’s  Marc Fisher, Lori Rozsa, Mark Kreidler and Annie Gowen report. 

Yet despite the massive death toll and the changes to daily life caused by the pandemic, the individual deaths are largely invisible.  

“Coronavirus victims who die in the hospital often spend their final days cut off from family and friends, their only human contact coming from medical personnel hidden behind layers of protective gear. Even those who die at home often decline in quarantine, keeping a lonely vigil over their body’s fight,” my colleagues write.

The numbers are expected to quickly rise. Rochelle Walensky, the incoming director of the Centers for Disease Control and Prevention, told “Face The Nation” on Sunday that she anticipated half a million deaths by mid-February.

“That doesn’t speak to the tens of thousands of people who are living with a yet- uncharacterized syndrome after they’ve recovered. We still yet haven’t yet seen the ramifications from holiday travel, holiday gathering in terms of high rates of hospitalizations,” Walensky added.

Here are six key ways Biden is promising to fight the coronavirus pandemic

By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.

Yet the crucial task he faces  rapidly distributing coronavirus vaccines to the American public  is one that most experts one year ago didn’t think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.

“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan. 

Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic. 

Here are six key promises Biden is making about his pandemic response:

1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.

Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations

The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.

The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.

“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”

But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.

“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News. “It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”

2. Set up mass vaccination clinics.

By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.

Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots. 

This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven’t.

“Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.

“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.

3. Allow federally qualified health centers to directly access vaccines.

These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.

Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.

Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.

How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.

Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”

4. Use the Defense Production Act to ensure plenty of vaccine supplies.

Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.

Ventilator tubes are attached to a covid-19 patient at Providence Holy Cross Medical Center in Los Angeles. 

He has used the DPA to speed the production of coronavirus tests and ventilators, and to keep meatpacking plants open. But he hasn’t invoked the authority to compel faster production of the supplies needed for packaging and administering the vaccine.

Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.

5. Sign executive actions to combat the virus.

Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.

On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”

The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.

“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.

6. Launch a vaccine education campaign.

The memo says Biden will run a “federally-run, locally-focused public education campaign.”

“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.

But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month. 

The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn. 

SOUTH DAKOTA’S CORONAVIRUS SURGE IS TURNING NURSING HOMES INTO A ‘BATTLE ZONE’

https://publicintegrity.org/health/coronavirus-and-inequality/south-dakota-covid-19-surge-nursing-homes-battle-zone/?fbclid=IwAR0Y4-pTgD3JzQN-h-aKHxFGto_qWKC9sXsY4U6gERp-dtKDI_kmccZxBWw

The state has lost a greater share of its nursing home residents to COVID-19 than any other state this fall.

On October 9, an employee in the business office at Tieszen Memorial Home in Marion, South Dakota, tested positive for the coronavirus. She was sent home immediately, but three days later, a nursing aide and a housekeeper both tested positive.

Marion, a town of fewer than 1,000 residents, was experiencing a sharp uptick in cases — what scientists call community spread. It became more and more likely that the nursing home’s employees had become infected while, for example, grocery shopping.

On October 16, COVID-19 killed its first Tieszen resident. At that point, about thirteen of the home’s 55 residents had tested positive.

Nursing home administrator Laura Wilson called the days that followed the worst of her career.

“You almost feel like a battle zone,” she said. “We said, ‘You know, right now, we just need to survive.’”

South Dakota Republican Gov. Kristi Noem has taken a notably relaxed approach to the pandemic. This autumn, months deep into this pandemic, nursing homes there have seen a larger share of their residents die than any other state.

At Jenkin’s Living Center in Watertown, 24 residents have died from COVID-19 since the last week of October — about a fifth of the residents there — data submitted to the federal government show. Thirteen patients at Weskota Manor in Wessington Springs  — more than a third of its patients — died from COVID-19 this autumn, most of them in one week. Walworth County Care Center in Selby, a 50-bed facility, saw COVID-19 kill 12 patients this autumn, an administrator said. Overall, more than 40 percent of South Dakota nursing homes have lost a tenth or more of their patients to the coronavirus, according to a Center for Public Integrity analysis of data from the federal Centers for Medicare and Medicaid Services.

Nationwide, more than 100,000 residents of long-term care facilities have died of COVID-19, making up 38% of the nation’s virus deaths, according to The Atlantics Covid Tracking Project,  even though they represent less than 1 percent of the population. 

The federal government has made protecting the elderly a priority, shipping millions of rapid tests to nursing homes across the country. Public health experts spent the first nine months of the pandemic perfecting strategies to keep the virus from spreading in close quarters. But, as researchers have learned, whether nursing home residents die from COVID-19 depends less on what happens inside than outside. Once COVID-19 permeates a town, there’s a limit to what nursing homes alone can do. 

And that has made South Dakota an especially deadly place.

A LONG STRING OF DEATHS

During Tieszen’s outbreak, the nursing home was eerily quiet. On a normal day, “The Price is Right” might blare from a room, echoing down the hallways. But when the coronavirus hit, all the residents’ doors had to be closed to try to control the spread.

Before October, Tieszen had pandemic challenges but not mass tragedy. Wilson was forced to hunt for N95 masks on eBay, even though South Dakota is home to a 3M factory that makes them. She relied on her son, who works at Sam’s Club, to buy one pack of disinfecting wipes every day for the nursing home’s stockpile. Back when she was using lab-confirmed tests to screen her staff, she had trouble getting test results back within the time recommended by federal guidelines, as the Sioux Falls lab she had contracted with was swamped. And she says, like always, staffing was a problem: Tieszen told the federal government it was short on nurses and aides every week in October and November.

Wilson, who has worked at the nursing home for 42 years, said her staff did everything it could during the outbreak. Indeed, Tieszen, a small nonprofit that has earned five stars in the federal government’s nursing home quality rankings, passed three state inspections of its infection-control program between May and November, records show. It received roughly $70,000 in CARES Act incentive payments from the federal government in September based on good performance.

When the coronavirus hit, the nursing home dedicated two of its wings to COVID-19 patients, isolating them from other residents, until so many contracted the virus that they had to stay in their rooms. The entire nursing home, essentially, became a COVID ward. Wilson’s own 85-year-old father tested positive. Nurses worked overtime; Wilson put in 80-hour weeks and hired temporary help. Staff served residents’ meals on paper plates instead of dishes that might retain the virus. They conducted weekly audits of how often staff were washing their hands. They tested workers and residents at any sign of a sniffle, as well as regularly regardless of symptoms, using equipment shipped to the nursing home from the federal government. They followed up positive rapid test results with lab-confirmed PCR tests.

Despite all of these measures, the virus spread quickly.

The week after Tieszen’s first death on October 16, five more residents died, Wilson said. Among them was 89-year-old Maxine Ortman, a former teacher suffering from dementia whose husband would visit often, before the pandemic, from his home across the street.

The following week, seven more died. 

In November, another seven died. They included 68-year-old Larry Johnson, a diabetic and former mechanic whose sense of humor and work ethic drew customers from all over northeastern South Dakota, his family wrote in his obituary.

And they included Randy Wieman, 64. He had Down syndrome, and died a week after testing positive for the virus, said his older sister, Carol Husby. He loved music, dancing and his many nieces and nephews. A normal December would find them celebrating Wieman’s birthday with chocolate cake. 

“He would call me every morning to ask if I was up,” Husby said. “Randy was an amazing individual.”

In total, 20 residents died of the coronavirus — more than a third of those living at the Tieszen nursing home — in the space of five weeks.

OUT-OF-CONTROL SPREAD

Tamara Konetzka, a health researcher at the University of Chicago, has been studying the fate of nursing homes in the pandemic since the spring.

Her conclusion: “Nothing much has changed.”

Despite more testing and efforts to hone infection control practices, despite nine months of scientific study of the virus, nursing home residents are still at the mercy of their surrounding communities. “If they’re in virus hotspots, they’re going to be at risk,” Konetzka said. “The idea that we have found the secret to preventing nursing home cases and death is a little crazy.”

And this autumn, nearly all of South Dakota has been a hotspot. The state has ranked at or near the top of all 50 states in new coronavirus cases and deaths for months in reports issued to governors by the White House Coronavirus Task Force. During one week prior to Thanksgiving, South Dakota had 988 new coronavirus cases per 100,000 residents — more than double the national average. It had 19.6 deaths per 100,000 residents — the worst rate in the nation and more than six times the national average.

The state’s governor, Noem, is widely believed to have national political ambitions. She has proudly shunned strict measures to curb the virus.
“Rather than following the pack and mandating harsh rules,” she wrote in The Wall Street Journal earlier this month, “we ask all South Dakotans to take personal responsibility for their health …. The state hasn’t issued lockdowns or mask mandates. We haven’t shut down businesses or closed churches.”

South Dakota Republican Gov. Kristi Noem has taken a relaxed approach to the pandemic, shunning strict measures to curb the virus. (AP Photo/James Nord, File)

Many South Dakotans have refused to wear masks or socially distance. In September, Wilson spoke at a meeting of local business owners in Marion and urged them to take mask-wearing seriously. She was met with blank stares. 

“When I left that meeting I had basically resigned myself to the fact that I am living in a different world, and they don’t get it,” she said. “I’d be the only person in the grocery store with a mask on.”

Though limiting community spread is the best way to protect nursing homes, researchers said, some measures — especially having enough staff — can affect the severity of outbreaks. Here is where the federal government failed spectacularly, experts said.
“What they needed — damn it — they needed money for more staffing,” said Larry Polivka, executive director of the aging-focused Claude Pepper Center at Florida State University. “And they needed all of the PPE. They needed massive testing capacity as quickly as possible in the spring — they didn’t get it.”

Wilson said the South Dakota Department of Health was helpful when she called or emailed with questions. The state continued to inspect nursing homes for infection control practices, and just 14 South Dakota nursing homes were cited by inspectors for inadequate infection control between March and October, according to federal data. The state has a program to recruit retired nurses and doctors to help work in healthcare settings. The federal government sent a “strike team” to South Dakota in October to help nursing homes tackle the coronavirus, a spokesman for CMS said in an email, and federal officials have offered training and guidance.

But it’s unclear what else, if anything, South Dakota did to help nursing homes weather the brutal autumn. For nine weeks in October and November, on average, nearly a quarter of all nursing homes in South Dakota told the federal government they were short on nursing staff, far more than the 16 percent that did so nationwide. On average, more than 40 percent of South Dakota nursing homes reported shortages of aides, more than double the nationwide figure. And 13 percent of South Dakota nursing homes during that time reported shortages of PPE — roughly the same as did nationwide. 

Policymakers of all stripes, even those who embrace a controversial “herd immunity” strategy and wish the virus to run free through the population, stress the need to protect long-term-care residents. Noem has not explicitly endorsed a herd immunity approach but has emphasized that the coronavirus is less likely to harm young people. She has acknowledged that the elderly face greater risks from the coronavirus. 

Yet the governor’s spokesperson did not answer questions from the Center for Public Integrity regarding nursing homes or respond to requests for comment. Noem’s health secretary did not respond to a request for an interview. The South Dakota Department of Health declined to answer multiple emails sent by Public Integrity over multiple weeks. The state’s long-term-care ombudsman refused through an agency spokesman to answer questions. When pressed, the spokesman said he did not know the reason but was given orders to decline the interview.

Even supposed advocates for nursing homes are reluctant to speak about the toll the coronavirus is taking on South Dakota’s elderly. Two trade associations representing nursing homes in the state declined interviews. One of them, the South Dakota Health Care Association, recommended that a reporter speak to the state department of health instead. Another lobbyist, who wished to remain anonymous to avoid angering the Noem administration, said people fear upsetting the governor’s office, known for its guarded approach to dealing with the media.

The state also waited until September to decide how to spend nearly $600 million in CARES Act funding approved by Congress in March. Noem finally set aside $115 million for nursing homes and other local health providers. But nursing homes had to apply for the funding during an 11-day period in October and meet strict qualifications. Tieszen applied but was not granted funds. Documents from the South Dakota Legislature dated Dec. 7 show that 115 health care organizations applied for the funding, and 47 were approved. But just $1.9 million had been handed out as of Dec. 18. The state is now proposing another grant program to distribute the money to health organizations based on bed numbers.

But for many nursing homes, the money comes too late to save lives. South Dakota may be past the worst of this COVID-19 surge. New coronavirus cases in the state are on the wane; vaccines are perhaps weeks away for nursing home residents at Tieszen and elsewhere.

All told, the state lost roughly one out of every 10 nursing home residents to COVID-19, according to federal data. 

“I don’t understand why people didn’t take it seriously right from the beginning,” Husby said. “It just breaks my heart because it didn’t have to be this way.”

2 months to slow the new spread

How does coronavirus spread: Community spread and COVID-19

🚨New CDC warning: The highly contagious variant B.1.1.7 originally detected in the U.K. could become the dominant strain in the U.S. by March.

Why it matters: The variant is estimated to be 30% to 50% more transmissible than other forms of the virus, threatening efforts to push the U.S. past its record high case count.

  • The variant is in 12 states, but has been diagnosed in only 76 of the 23 million U.S. cases reported to date, the AP reports.
  • It’s likely that the variant is more widespread than currently reported.

The big picture: Americans are exhausted and burned out, and COVID wariness is slipping.

  • So far, the variants do not appear to be resistant to the existing vaccines or cause more severe disease.
  • But the health care system is on the brink in places like Southern California.
  • Another spike in cases could lead us to a very dark place.

The bottom line: There’s no evidence that this variant is transmitted differently, so keep up the masks and social distancing.

Go deeper … The coronavirus variants: What you need to know.

CDC warns highly transmissible coronavirus variant to become dominant in U.S.

The highly contagious variant of the coronavirus first seen in the United Kingdom will become the dominant strain in the United States within about two months, its rapid spread heightening the urgency of getting people vaccinated, the Centers for Disease Control and Prevention predicted Friday in its most sobering warning yet about mutations in the virus.

In every scenario explored by the CDC, the U.K. strain, which British researchers estimate is roughly 50 percent more transmissible than the more common coronavirus strain, will account for a majority of cases in the United States by some point in March.

The CDC released modeling data to back up its forecast showing a rapid spike in infections linked to the U.K. strain. The agency said the emergence of these mutation-laden variants requires greater efforts to limit viral spread — immediately, even before the U.K. variant becomes commonplace.

So far, no variant is known to cause more severe illness, although more infections would inevitably mean a higher death toll overall, as the CDC made clear in an informational graphic released Friday: “MORE SPREAD — MORE CASES — MORE DEATHS,” it said.

The CDC report “speaks to the urgency of getting vaccines out. It’s now a race against the virus,” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

Scientists both in and out of government have stressed the need for the public to stick to proven methods of limiting viral spread, such as wearing a mask, social distancing, avoiding crowds and having good hand hygiene.

“We know what works and what to do,” CDC scientist Jay Butler said Friday.

The emergence of highly contagious variants has grabbed the full attention of scientists, who in recent weeks have warned that these mutations require closer surveillance. The CDC and its partners in private and academic laboratories are ramping up genomic sequencing efforts to gain better awareness of what is already circulating. Experts think there could be many variants containing mutations worth a closer look.

“This is a situation of concern. We are increasing our surveillance of emerging variants. This virus sometimes surprises us,” Butler said.

Mutations could limit the efficacy of vaccines or therapeutic drugs such as monoclonal antibodies. Scientists believe vaccines will probably remain effective because they produce a robust immune system response, but such reassurances have been paired with cautionary notes about how much remains unknown.

The coronavirus mutations are not unexpected, because all viruses mutate. There are now several “variants of concern” receiving close scrutiny, including ones identified first in South Africa and Brazil, and U.S. officials have said genomic surveillance is still ramping up here and that there may be other variants in circulation, not yet identified, that are enhancing transmission.

“We’re going forward with the assumption that these three variants that we know about now are not going to be the only variants that emerge that are of concern to us,” Greg Armstrong, head of the CDC’s strain surveillance program, said Friday.

The CDC model suggests that the level of pain and suffering in March, when the new variant is expected to be dominant, depends on actions taken today to try to drive down infection rates. Because the threshold for herd immunity depends in part on how infectious a virus is, the emergence of a more transmissible strain can prolong efforts to crush a pandemic.

The emergence in recent weeks of mutation-laden variants has alarmed the CDC and the scientific community because of accelerating infections in Britain, Denmark, Ireland and other countries where the variant named B.1.1.7 has been spreading.

“Increased SARS-CoV-2 transmission might threaten strained healthcare resources, require extended and more rigorous implementation of public health strategies, and increase the percentage of population immunity required for pandemic control,” the CDC wrote. “Taking measures to reduce transmission now can lessen the potential impact of B.1.1.7 and allow critical time to increase vaccination coverage.”

It is unclear if the winter surge in the United States is at a peak, but the numbers are staggering, with more than 200,000 new infections confirmed every day on average.

This is not the first warning from the CDC about variants of the virus, but it is the first to offer a plausible timeline for when and to what degree the mutations seen recently could complicate efforts to end the pandemic.

It shows that vaccination, performed rapidly, is critical to crushing the curve of viral infections. Without vaccines, under one CDC scenario, the country could be dealing with even greater levels of infections in May than in January.

But if public health agencies can ramp up to 1 million vaccinations a day, the CDC model forecasts that daily new infections will decline in the next few months — even with the extra boost from the highly contagious U.K. variant. It has been identified in 12 states, the CDC said Friday, and the agency has informed officials nationwide that they should assume the variant is present in their state.

The CDC and unaffiliated scientists have said they see no evidence that this particular variant is driving the winter surge in cases. So far, it has been involved in fewer than 0.5 percent of infections nationwide, testing data suggests.

Friday’s sobering CDC forecast is based on simple models and has limitations, the agency acknowledged.

The model looks at just the B.1.1.7 variant and does not consider the impact of other variants already discovered or not yet identified. The variants in South Africa and Brazil could prove to be even more problematic, though they have not been spotted so far in the United States. Researchers have noted the disastrous spike in cases in Manaus, Brazil, in recent weeks, despite the high percentage of the population believed to have been previously infected — a situation that raises suspicions, not confirmed by data, that some people who had recovered are becoming re-infected by the new strain.

The CDC model treats the country as a single unit even though the virus is spreading at different rates locally and regionally. No one knows, even at the national level, the current “R,” the reproduction number, of the common coronavirus variant. That’s the number of people an infected person will infect, on average.

The CDC model used plausible reproduction rates of 1.1 (faster spread right now) and 0.9 (slower). The CDC then used British data to project that the U.K. variant is 50 percent more transmissible than the common variant. The model assumes that between 10 and 30 percent of the population has been infected already and recovered and now has immunity.

“It would be foolish to say that this is never going to end, and we might as well stop trying,” the CDC’s Butler said Friday. “But there is reason to be concerned. We’re not out of the woods on this pandemic yet. We need to continue to press ahead.”